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Full Time Job Summary: The Nurse Navigator (Research) ensures the clinical assessment and clinical care provided to research subjects meets all regulatory requirements and research protocol. This position understands the disease process and research treatment. This role provides education and coordination to research participant consumers (patients, survivors, families, and caregivers) to help them navigate participation in a clinical trial within the healthcare system. Navigators help their research subjects move through the complexities of clinical trial participation by assessment, planning, implementation and documentation of the care rendered to patients on research protocols and coordination of all aspects of patient care related to the protocols including data collection and compliance requirement. Advises and consults with physician investigators and study sponsors to ensure research protocol adherence. Minimum Education: Bachelor's degree in nursing. Licensure, Registration and/or Certification: Valid multi-state or State of Oklahoma Registered Nurse License. Work Experience: Minimum 4 years of clinical nursing experience in high acuity setting e.g. intensive care, cardiac, neuro, trauma or oncology, for service line research. Experience in risk management or other highly regulated fields, preferred. Knowledge, Skills and Abilities: Outstanding attention to detail. Ability to independently use critical thinking skills to effectively solve problems and use conceptual thinking to anticipate impact of decisions; Superb communication skills and ability to communicate effectively in a variety of settings and styles; Effective written and verbal instructions to patients: Follow, interpret, and carry out written and verbal instructions; perform arithmetic, algebraic, and geometric calculations according to research protocols, compose original correspondence for nursing documentation. Proficient computer skills including MS Office, Word, Excel, PowerPoint, electronic protocol data submission programs, electronic medical records programs with ability to adapt to and learn additional computer applications. Strong knowledge of FDA regulations, 45 CFR 46. ICH guidelines, and Good Clinical Practices and their application to clinical trials. Comfortable in high acuity settings and working autonomously. Essential Functions and Responsibilities: Directs and oversees the daily activities of research protocols - screening patients for protocol eligibility requirements and determining data requirements as delineated by each individual research protocol. Randomizes patients appropriately, develops treatment plan according to specified protocol, collects appropriate data from physician offices and patient charts. Assures adequate documentation of all protocol-related parameters. Performs protocol-specific clinical tasks as needed such as toxicity assessments and assist physicians in response evaluations. Identifies and provides patient and family educational needs regarding treatment management, evaluation and follow-up in clinical trials through talking with patient's person-to-person or by telephone and/or through written educational material. If necessary, administers investigational medications following acceptable nursing procedures/guidelines. Orders protocol related tests, procedures, medications as directed by the physician investigators and acceptable nursing procedures/guidelines. When appropriate, obtains informed consent through patient education; instructs patients regarding study design and purpose, anticipated side effects, patient's responsibilities and rights. Instructs. coaches. and/or trains the research data analysts and research coordinators to ensure that protocol parameters and treatment guidelines are correctly applied and carried out. Observes, analyzes, assesses, and reports all unanticipated problems according to the guidelines set forth by the FDA, OHRP, the National Cancer Institute, specific research groups, and IRB. Provides clinical nursing review of protocol-related documents (new protocols, protocol modifications, blurbs screening sheets, safety alerts, etc.). Serves as a clinical research resource regarding protocol specifics to physician investigators and the scientific review committee. Interfaces with research sponsors and participates in on-site qualification and monitoring visits. Decision Making: The carrying out of non-routine procedures under constantly changing conditions, in conformance with general instructions from supervisor. Working Relationships: Coordinates activities of others (does not supervise). Leads others in same work performed (does not supervise). Has input on performance evaluations but does not prepare or give. Works directly with patients and/or customers. Works with internal and/or external customers via telephone or face to face interaction. Works with other healthcare professionals and staff. Works frequently with individuals at Director level or above. Special Job Dimensions: None. Supplemental Information: This document generally describes the essential functions of the job and the physical demands required to perform the job. This compilation of essential functions and physical demands is not all inclusive nor does it prohibit the assignment of additional duties. Clinical Research and Sponsored Programs - Yale Campus Location:The Pharmacist-in-Charge (PIC) is responsible for overseeing the daily operations of the pharmacy, ensuring compliance with all applicable laws and regulations, and delivering high-quality pharmaceutical care. As PIC, you have a critical role at the forefront of delivering...
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